An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039506
• Other study ID #: TOP009-061
• Secondary ID: 090945
• Status: Completed
• Start date: October 15, 2009
• Est. completion date: July 1, 2016

Study information

• Verified date: May 2019
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1376
• Est. completion date: July 1, 2016
• Est. primary completion date: April 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Metastatic colorectal cancer (adenocarcinoma)

• UGT1A1 genotyped patients

• Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion Criteria:

• Contraindication of CPT-11

• Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4

• Patients to receiving CPT-11 as adjuvant chemotherapy

• History of pelvic irradiation

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• CPT-11 based regimens

Locations

Country	Name	City	State
Japan	Department of Clinical Oncology, National Defense Medical College Hospital	Tokorozawa-shi	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Percentage of participants alive without disease progression	Within 3 years
Secondary	Overall survival	Percentage of participants alive at end of study	At 3 years
Secondary	Time to treatment failure	Duration of time (in months) from treatment to failure	Within 3 years
Secondary	Response rate	Percentage of participants with an objective response	from Day 1 (treatment) through disease progression (within 3 years)
Secondary	Disease control rate	Percentage of participants with controlled disease	Within 3 years
Secondary	Safety events	Adverse events will be collected during treatment	Within 3 years